1. Field of the Invention
The present invention relates to computer-implemented methods and systems for analyzing the effectiveness of pharmaceutical treatments and, more specifically, for determining the effectiveness of pharmaceutical treatments utilizing real time prescription compliance records.
2. Description of the Related Art
Clinical studies have been used for many years to help the medical industry determine or verify the effects of pharmaceutical treatments on human subjects having various ailments or medical conditions. Clinical studies are typically conducted by universities or hospitals that are either trying to determine how a certain drug or pharmaceutical treatment affects a patient with a particular medical condition or how a certain medical condition can be affected by various pharmaceutical medication and treatments. Other purposes of clinical studies can also include determining side effects of treatment, determining if the benefits outweigh the side effects of the treatment, and determining which patients the treatment is most likely to help.
Before a medication can be sold to consumers, either over-the-counter or through a prescription, the medication must be rigorously tested on human subjects. To be eligible for approval by the Food and Drug Administration (FDA), a medication must be studied, typically in three clinical trial phases. The purpose of the first phase, or Phase I, clinical study is to determine the safety of the medication. In Phase I clinical studies, a goal is to find the best way to give a new treatment and how much of it can be given safely. Study administrators, who are often physicians, typically monitor patients very carefully, often in a hospital setting, for any harmful side effects. At this point, the pharmaceutical treatment has been well tested in laboratory and animal studies, but the side effects in humans are not completely known. Study administrators usually start by giving very low doses of the pharmaceutical treatment to the first patients and increasing the dose for later groups of patients until side effects appear. Although study administrators are hoping to help patients, the main purpose of such a Phase I study is to test the safety of the pharmaceutical treatment. Some Phase I clinical trials are designed to fine-tune a regimen such as combining two well known drugs before going into Phase II studies, and although the safety is being established, such studies usually give drug doses that have already been shown to be at least partially effective.
Once a medication has been determined to be safe in human subjects, such as by Phase I testing, the pharmaceutical treatment must then be tested in the patients that have the target disease or medical condition that the pharmaceutical treatment is expected to help or cure. This phase, Phase II, of the clinical studies typically includes ensuring the safety and effectiveness of the pharmaceutical treatment in the patient population of interest. Generally, patients are given the highest dose that does not cause severe side effects, which is based on the results of the Phase I study, and closely observed for an effect on the target disease or medical condition at issue. Study administrators will also look for additional side effects that may be present in this group of patients having the disease or condition at interest.
In Phase III clinical studies, the pharmaceutical treatment is given to a much larger patient population of interest. Some clinical studies can enroll thousands of patients. The large-scale testing enables doctors to understand the effectiveness of the pharmaceutical treatment, the benefits and risks of the pharmaceutical treatment, and the range or severity of possible adverse side effects.
Several problems exist with current clinical studies. One problem is that the subjects of the study are typically not monitored on a continuous basis. The subjects periodically check in and have various tests performed to determine if the pharmaceutical treatment has had any affect on their medical condition. The subject is typically asked if they have been taking their pharmaceutical treatment, as prescribed. If subjects have not been taking the pharmaceutical treatment as prescribed and yet indicate that they have been taking the treatment as prescribed, then the results of the clinical study are not accurate. To compound the problem, many subjects are paid for their participation in the study, which provides an incentive for the subject to tell the study administrator that they have been taking the treatment as prescribed, when in fact they have not.
With some treatments, if the subject does not take the pharmaceutical treatment as prescribed at least a preselected portion of the time, i.e., 15% of the time, the pharmaceutical may actually have adverse effects on the subject. Without actual data regarding how often the subject took the pharmaceutical treatment, it is difficult to determine with certainty the effectiveness of the pharmaceutical treatment.
Another drawback of conventional clinical studies is that typically only the targeted parameter is monitored, as opposed to the overall health of each clinical study. For example, if a hospital is trying to determine the effectiveness of a new cholesterol reducing medication, typically only the cholesterol will be monitored on the subject. If the treatment made the subject's resting heart rate lower, this may not be recognized or noticed by the clinical administrator. Various treatments may affect more than the targeted parameter. Without continuous overall health monitoring, the side effects other than with regard to the targeted parameter may not be noticed by the clinical administrator.
Correctional facilities have a large population of inmates that have various medical conditions that require constant medical monitoring and administration of pharmaceutical treatments. Correctional facilities closely monitor and track medical conditions through the use of such systems as electronic medical records, as described in co-pending U.S. patent application Ser. No. 10/806,878, of which the present application is a continuation-in-part. The electronic medical records have been used to record such events as provider visit results, prescription histories, lab work results, and the like. The electronic medical records typically have been developed and maintained either by the correctional facilities or by a third party that has been providing healthcare services for the correctional facility system.
Medicinal administrators within correctional facilities are also required to maintain records associated with the physical administration and dispensation of prescribed pharmaceutical treatment to inmates. Inmates by law must have proper medical care while in the custody of the correctional facilities. To provide sufficient evidence that the correctional facilities have exerted their best efforts to provide proper medical care, the correctional facilities have maintained records indicating the time, type, and dosage of each pharmaceutical treatment that was administered to an inmate. A guard has been present during pharmaceutical treatment administration to ensure that the inmates actually consumed their prescribed pharmaceutical treatments, unless, as in rare circumstances, the inmates were allowed to keep the medication on their person, referred to as “keep-on-person” medication. The correctional facility has kept records indicating whether or not the inmate has actually took the pharmaceutical treatment. Many times the records are either paper based or kept on a standalone computer system. Since the implementation of such methods and systems the number of grievances filed by inmates has drastically reduced.
Clinical studies have been performed on inmates who volunteered to be test subjects in the studies. Problems existed in the past because there was no guarantee that the inmate took the pharmaceutical treatment as prescribed.